NCT03119883

Brief Summary

This clinical trial studies the utilization of glutamine by the bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) compared to multiple myeloma (MM). Results from this study may identify metabolic differences between pre-malignant and malignant clonal plasma cells in MGUS and MM, respectively. It may also allow researchers better determine the transition from MGUS to MM for the development of potential early diagnostic purposes of preventative strategies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 2, 2017

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

7.1 years

First QC Date

April 12, 2017

Last Update Submit

August 7, 2024

Conditions

Monoclonal Gammopathy of Undetermined SignificancePlasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

  • Percent enrichment of 13-Carbon in the tricarboxylic acid (TCA) cycle intermediates within bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma

    Will compare the glutamine anaplerosis activity in bone marrow clonal plasma cells between patients with MGUS and multiple myeloma.

    Up to 1 day

Secondary Outcomes (2)

  • Percent enrichment of 13-Carbon in the TCA cycle intermediates within bone marrow plasma from patients with MGUS and multiple myeloma

    Up to 1 day

  • Percent enrichment of 13-Carbon in the TCA cycle intermediates within the peripheral blood plasma from patients with MGUS and multiple myeloma

    Up to 1 day

Study Arms (2)

Group I (biospecimen collection)

EXPERIMENTAL

EX-VIVO: After an overnight fast of 6 hours, patients undergo collection of bone marrow aspirate samples.

Procedure: Biospecimen Collection

Group II (biospecimen collection, glutamine, glucose)

EXPERIMENTAL

IN VIVO: After an overnight fast of 6 hours, patients receive 13-carbon labeled glutamine or 13-carbon-labeled glucose IV over 90 minutes. Patients also undergo collection of blood and bone marrow aspirate samples.

Other: 5-Carbon C 13-labeled GlutamineProcedure: Biospecimen CollectionOther: Uniformly-labeled [13C]glucose

Interventions

5-Carbon C 13-labeled GlutamineOTHER

Given IV

Also known as: 5-13C-Glutamine, [5-13C]-glutamine, GLUTAMINE 5-C-13
Group II (biospecimen collection, glutamine, glucose)
Biospecimen CollectionPROCEDURE

Undergo collection of blood

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Group II (biospecimen collection, glutamine, glucose)
Uniformly-labeled [13C]glucoseOTHER

Given IV

Also known as: [U-13C] Glucose, U-13C-Glucose
Group II (biospecimen collection, glutamine, glucose)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • International Myeloma Working Group (IMWG) criteria for the diagnosis of either MGUS or MM

You may not qualify if:

  • Unable to provide consent
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 3
  • Hemoglobin \< 8 g/dL
  • Women who are pregnant
  • Prior history of adverse events with conscious sedation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Gonsalves WI, Jang JS, Jessen E, Hitosugi T, Evans LA, Jevremovic D, Pettersson XM, Bush AG, Gransee J, Anderson EI, Kumar SK, Nair KS. In vivo assessment of glutamine anaplerosis into the TCA cycle in human pre-malignant and malignant clonal plasma cells. Cancer Metab. 2020 Dec 11;8(1):29. doi: 10.1186/s40170-020-00235-4.

    PMID: 33308307DERIVED

Related Links

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined SignificanceMultiple Myeloma

Interventions

Specimen HandlingGlucose

Condition Hierarchy (Ancestors)

HypergammaglobulinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesParaproteinemiasImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersLymphoproliferative Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Wilson I Gonsalves, M.D.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 19, 2017

Study Start

June 2, 2017

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations

US(1)